A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation

November 2, 2026 updated by: Medical University of South Carolina

A Micro-Randomized Trial to Optimize a Just-in-Time Adaptive Intervention for Alcohol Craving and Suicide Ideation

This study will develop and evaluate a brief, personalized, single-session telehealth intervention combined with a four-week just-in-time adaptive intervention (JITAI) delivered via text messaging for adults with alcohol use disorder (AUD) and suicidal thoughts and behaviors. The study includes qualitative interviews, pilot testing, and a 28-day micro-randomized trial (MRT). In the MRT phase, participants (N=75) will be repeatedly randomized multiple times per day to receive text messages targeting craving and suicide ideation or to receive no message. Outcomes include alcohol craving, suicide ideation, alcohol consumption, and engagement with intervention strategies

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Margaret M Baer, PhD
  • Phone Number: 567-218-3067
  • Email: baerm@musc.edu

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Medical University of South Carolina
        • Contact:
          • Margaret M Baer, PhD
          • Phone Number: 567-218-3067
          • Email: baerm@musc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 years or older
  • Meets DSM-5 criteria for current (past 6 months) Alcohol Use Disorder (mild, moderate, or severe)
  • Reports at least one episode of suicidal ideation in the past 6 months
  • Currently engaged in alcohol use treatment (at least monthly participation in outpatient or intensive outpatient individual or group treatment)
  • Alcohol identified as primary substance of use
  • Resides in the United States
  • Owns a personal smartphone
  • Able and willing to provide informed consent
  • Co-occurring mood disorders (excluding bipolar disorder), anxiety disorders, or other substance use disorders are permitted

Exclusion Criteria:

  • Current suicidal or homicidal intent
  • Suicide attempt within the past 3 months
  • Psychiatric hospitalization within the past 3 months
  • Current or past psychotic disorder or bipolar disorder
  • Alcohol withdrawal requiring medical management (e.g., CIWA-Ar score > 8)
  • Inability or unwillingness to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single arm. Groups of people are not randomized. Each person is repeated randomized.

Groups of people are not randomized. Each person is repeated randomized 112 times over 28 days to text message vs no text message. Within the text message condition, there is additional randomization to text message choice and text message language conditions.
Behavioral: Text Message (to remind of Integrated Plan content)

At four time points each day (112 time points across the 28-day study), each participant will be randomized to text message or no text message. Within the text message condition, there will be further randomization to Text Message Choice and Text Message Language conditions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Integrated Plan Engagement
Time Frame: 28-day MRT period

Participants will complete the following yes/no EMA item four times a day: "Since the last survey, I completed a strategy from my Integrated Plan." This item, created by the study team for this study, will assess the completion of any intervention strategy from the patient's individualized Integrated Plan during the 28 day period.
28-day MRT period
Alcohol Craving
Time Frame: 28-day MRT period

Participants will complete the following EMA item (on a 0-10 Likert scale) four times a day: "Since the last survey, I thought about drinking or how good a drink would make me feel." This item, drawn from a well-established measure of alcohol craving (Penn Alcohol Craving Scale) will assess craving during the 28 day period.
28-day MRT period
Suicide Ideation
Time Frame: 28-day MRT period

Participants will complete the following EMA item (on a 0-10 Likert scale) four times a day: "Since the last survey, I thought about killing myself." This item, drawn from a well-established interview that has also been used as a self-report measure to assess varied self-injurious thoughts and behaviors (Self-Injurious Thoughts and Behaviors Interview-Revised) will assess thoughts of suicide during the 28 day period. This item has been used previously by the PI in EMA studies.
28-day MRT period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Alcohol Consumption
Time Frame: 28-day MRT period

Participants will complete the following EMA item to assess alcohol consumption four times a day: "Since the last survey, I drank __ drinks".
28-day MRT period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Margaret M Baer, PhD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00151349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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